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Clinical Trials/NCT05903274
NCT05903274TerminatedPhase 1

A Phase 1 Open-label, Dose-escalation, Safety, and Tolerability Study of JSP191 As a Second-line Therapy in Subjects with Lower-Risk Myelodysplastic Syndrome (LR-MDS)

Jasper Therapeutics, Inc.2 sites in 1 country6 target enrollmentStarted: June 19, 2023Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Terminated
Enrollment
6
Locations
2
Primary Endpoint
Safety and tolerability of JSP191

Study Overview

Brief Summary

A Phase 1 study in subjects with LR-MDS to assess the safety and tolerability of JSP191 as a second-line therapy.

Detailed Description

An open-label, single-arm, dose-escalation study designed to determine the potential safety, efficacy, maximum tolerated dose (MTD) or optimal biologic dose (OBD), and recommended phase 2 dose (RP2D) of JSP191 (briquilimab) monotherapy for LR-MDS subjects with documented cytopenia (red blood cell-transfusion dependent, thrombocytopenia, and/or neutropenia).

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Sequential
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age ≥ 18 years
  • MDS with IPSS-R very low, low, or intermediate risk features
  • Symptomatic cytopenias
  • Women of childbearing potential (WOCBP) must agree to use an oral or implanted contraceptive, a double-barrier method of birth control, or an intrauterine device upon enrollment and through 3 months after receiving the last dose of JSP191
  • Women not of childbearing potential must be post-menopausal (no menstrual period for a minimum of 12 months) or surgically sterilized and have a negative serum pregnancy test upon study entry
  • Male subjects must be surgically sterile or willing to use contraception upon enrollment and through 3 months after receiving the last dose of JSP191
  • Must be willing and able to provide informed consent

Exclusion Criteria

  • Anemia secondary to iron deficiency, vitamin B12 deficiency, or folate deficiency
  • Prior allogeneic or autologous stem cell transplant
  • Known history of human immunodeficiency virus (HIV) (no laboratory testing is required), or active infection with hepatitis B or hepatitis C
  • Pregnant women or women who are nursing and do not wish to discontinue breastfeeding
  • Any other medical condition that, in the opinion of the Investigator, could pose a significant safety risk to the subject or jeopardize the integrity of the study
  • Subjects who, in the opinion of the Investigator, may not be able to comply with the requirements of the study

Arms & Interventions

JSP191

Experimental

This study will explore up to 5 ascending dose levels (Cohorts 1, 2, 3, 4, and 5) and subjects will receive JSP191 on Day 1 on each 8-week cycle for 4 consecutive cycles.

Intervention: JSP191 (Drug)

Outcomes

Primary Outcomes

Safety and tolerability of JSP191

Time Frame: 32 weeks

Assessed by the frequency, duration, and severity of adverse events

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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